STEPFORWARD study : a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations

Vanicek, N ORCID: https://orcid.org/0000-0002-9602-3172, Coleman, E, Watson, J ORCID: https://orcid.org/0000-0003-0694-3854, Bell, K, McDaid, C ORCID: https://orcid.org/0000-0002-3751-7260, Barnett, C, Twiste, M ORCID: https://orcid.org/0000-0003-2724-3283, Jepson, F, Salawu, A ORCID: https://orcid.org/0000-0003-2496-0826, Harrison, D and Mitchell, N 2021, 'STEPFORWARD study : a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations' , BMJ Open, 11 (3) , e045195.

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Abstract

Objectives: To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot. Design: Multicentre parallel group feasibility RCT. Setting: Five prosthetics centres in England recruiting from July 2018 to August 2019. Participants: Adults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having ‘limited community mobility’ and using a non-self-aligning ankle-foot. Intervention: Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. Outcomes: Feasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire. Results: Fifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%–94%, and clinical assessments were 92%–95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively. Conclusions: This feasibility trial recruited and retained participants who were categorised as having ‘limited community mobility’ following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery. Trial registration number: ISRCTN15043643.

Item Type: Article
Additional Information: ** Embargo end date: 18-03-2021 ** From BMJ via Jisc Publications Router ** Licence for this article starting on 18-03-2021: https://creativecommons.org/licenses/by/4.0/ **Journal IDs: eissn 2044-6055 **Article IDs: publisher-id: bmjopen-2020-045195 **History: published_online 18-03-2021; published 03-2021; accepted 23-02-2021; rev-recd 18-02-2021; submitted 26-09-2020
Schools: Schools > School of Health and Society
Journal or Publication Title: BMJ Open
Publisher: BMJ Publishing Group
ISSN: 2044-6055
Related URLs:
Funders: National Institute for Health Research (NIHR), Hull University Teaching Hospitals NHS Trust
SWORD Depositor: Publications Router
Depositing User: Publications Router
Date Deposited: 22 Mar 2021 10:57
Last Modified: 28 Aug 2021 10:57
URI: http://usir.salford.ac.uk/id/eprint/59905

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